Study of SSS06 for Chemotherapy-Induced Anemia in Non-Myeloid Malignancies
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShenyang Sunshine Pharmaceutical Co., LTD.
About this trial
This study employs a multicenter, randomized, open-label, positive drug-controlled, multiple ascending dose clinical trial design to comprehensively evaluate the safety, tolerability, immunogenicity, and pharmacokinetic characteristics of SSS06 injection in patients with chemotherapy-induced anemia from non-myeloid malignancies, while also exploring its potential efficacy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female participants aged ≥18 years at the time of signing the informed consent.
Histologically or cytologically confirmed diagnosis of non-myeloid malignancies.
Chemotherapy-induced anemia defined as hemoglobin (Hb) ≤100 g/L at screening, with a documented decrease in Hb of ≥10 g/L post chemotherapy initiation, as judged by the investigator.
Serum ferritin ≥50 ng/mL and transferrin saturation (TSAT) ≥10% at screening.
Disqualifiers
Patients undergoing myelosuppressive chemotherapy with an expected curative outcome.
Subjects receiving only hormone therapy, biologics, immunosuppressants (e.g., PD-1 and PD-L1 immune checkpoint inhibitors), or targeted therapies, or radiation therapy to treat/control their tumors; however, subjects receiving chemotherapy in combination with these therapies may be included.
Subjects with a hematocrit (HCT) ≥ 36%.
Subjects who have undergone interventions (e.g., blood transfusion, erythropoiesis-stimulating agents (ESAs), or hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs)) to elevate hemoglobin (Hb) levels to meet chemotherapy safety standards prior to the initiation of the scheduled chemotherapy regimen.
Trial design
Design model
Parallel
Treatments tested in this trial
SSS06
DrugSSS06 is a highly glycosylated, long-acting recombinant protein product produced through recombinant gene technology by introducing site-specific mutations into the rHuEPO gene.
rhEPO
Druga recombinant human erythropoietin injection.
Treatment groups
80 Participants
are divided into 4 treatment groupsGroup A: Low-dose groupExperimental treatment 1 intervention
Group B: medium-dose groupExperimental treatment 1 intervention
Group C: high-dose groupExperimental treatment 1 intervention
Group D: Positive control groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) Events (NCI-CTCAE V5.0).
All adverse events occurring during the entire study period will be assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE Version 5.0).
Time frame
From Day 1 to Day 113Secondary outcomes
1
Concentration of hemoglobin maximum change from baseline
the maximum change in Hb from baseline within 13 weeks without red blood cell transfusion.
Time frame
From Day 1 to Day 113Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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